TandemHeart- TRIS

Basic Information

• Brand Name: TandemHeart- TRIS
• Primary DI: 00814112020234
• Version / Model: 5140-6221TRIS
• Company Name: CARDIACASSIST, INC.
• Labeler DUNS: 948683941
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-10-15
• Public Version: 4
• Public Version Date: 2018-10-03
• Public Version Status: Update
• Public Device Record Key: e8671a6c-7712-4741-a905-32a05ad419ce
• Distribution End Date: 2015-11-13

Device Description

21 Fr x 62 cm venous cannula with dilator and introducer

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: Yes
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	870.4210	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46849	Circulatory assist transseptal cannula	A sterile tubular device designed for cannulation of the left atrium through the atrial septum, via the femoral vein, to drain the atrium and provide a means for temporary (less than six hours) left ventricular bypass [percutaneous transseptal ventricular assist (PTVA)]. It is a semi-rigid device (also known as a transseptal catheter) which may have a curved distal tip to better conform to the anatomy. Once in situ it is connected to an extracorporeal blood pump which returns blood to the patient. Disposable device dedicated to catheter introduction/function (e.g., obturator, dilator) may be included. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00814112020234	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K052570	000

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 15 – 85 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 0 – 40 Degrees Celsius